Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02781779

Enrollment

147

Registered

2016-05-24

Start date

2016-06-30

Completion date

2017-12-31

Last updated

2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Wounds and Injuries

Keywords

Cardiac Implantable Electronic Device, Implant

Brief summary

The purpose of this study is to learn how effective each of the two dressings, Silverlon® and AQUACEL® AG, are in preventing post cardiac implantable electronic devices (CIED) procedure wound infections.

Detailed description

This is a single center, prospective, 2-arm randomized, non-blinded study. A total of 100 participants will be assigned to the Silverlon arm and 100 to the AQUACEL AG arm. The number of procedures to implant CIED has risen in recent years. With this rise has also brought a rise in post-procedure infections. Infections will happen and there is a continued need to improve all aspects of the surgery and post-operative care. Wound coverage with appropriate dressings is one aspect that needs to be studied in CIED implant patients. Silverlon and AQUACEL AG are two options of dressings available for these patients. This study will look to see if one of the two is a better option for post-operative CIED implant patients.

Interventions

DEVICESilverlon®

Silverlon wound dressings

DEVICEAQUACEL® AG

AQUACEL® AG wound dressings

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who are scheduled for a CIED implant, generator change, or upgrade at the University of Kansas Hospital * Able to give informed consent

Exclusion criteria

* Patients who are already on antibiotics for another reasons * Immunocompromised patients such as those on immunosuppressant's and HIV positive patients * Patients who are post device explant for lead infection * Patients with an allergy to adhesive, silver or an allergy to the dressing(s) or their components

Design outcomes

Primary

Measure	Time frame	Description
Pocket Hematoma, Moderate-Severe	7-10 days post implant	A pocket hematoma is an accumulation of blood in or near the surgical incision which occurs because of a defect in hemostasis such as injury to blood vessels. Pocket hematoma is associated with local discomfort, an increased risk of infection, and may require surgical intervention or lead to lengthier hospital stays. Mild - Ecchymosis or mild effusion in the pocket, no swelling or pain to device-pocket (watchful waiting) Moderate - Large effusion in the pocket leading to swelling and causing functional impairment or pain to device-pocket Severe - Any pocket hematoma requiring: Reoperation and/or resulting in prolongation of hospitalization (defined as extended hospitalization or rehospitalization for \>24 hours, postindex surgery, primarily due to hematoma) and/or requiring interruption of OAC (defined as reversal or intentional withholding, in response to pocket hematoma, resulting in subtherapeutic anticoagulation for \>24 hours)

Secondary

Measure	Time frame	Description
Wound Drainage	At time of dressing removal, up to 10 days post operative	Number of participants with wound drainage
Pocket Dehiscence	At time of dressing removal, up to 10 days post operative	Pocket (Wound) Dehiscence: Dehiscence is a partial or total separation of previously approximated wound edges, due to a failure of proper wound healing. It may be just the surface layer or the whole wound.This scenario typically occurs 5 to 8 days following surgery when healing is still in the early stages.
Rash After Removal	At time of dressing removal, up to 10 days post operative	Number of participants with rash after dressing removal
Site Itching/Burning	At time of dressing removal, up to 10 days post operative	Number of participants with Site itching/burning
Skin Erythema	At time of dressing removal, up to 10 days post operative	Number of participants with skin erythema

Countries

United States

Participant flow

Recruitment details

Prospectively enrolled patients undergoing CIED implantation, upgrade, or generator change from June 2016-June 2017 were randomized to receive one of the two dressings at the end of the procedure.

Pre-assignment details

Immunocompromised patients and those on non-standard antibiotic regimens were excluded.

Participants by arm

Arm	Count
Silverlon® Subjects randomized to this arm will receive Silverlon® dressing postoperative. Silverlon®: Silverlon wound dressings	78
AQUACEL® AG Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative. AQUACEL® AG: AQUACEL® AG wound dressings	69
Total	147

Baseline characteristics

Characteristic	Total	AQUACEL® AG	Silverlon®
Age, Continuous	69 Years STANDARD_DEVIATION 14	68.5 Years STANDARD_DEVIATION 14.2	70.4 Years STANDARD_DEVIATION 13.7
body mass index (BMI)	29.79 kg/m^2 STANDARD_DEVIATION 6.06	29.9 kg/m^2 STANDARD_DEVIATION 5.7	29.7 kg/m^2 STANDARD_DEVIATION 6.3
Chronic Kidney Disease (CKD)	35 Participants	15 Participants	20 Participants
Diabetes	49 Participants	22 Participants	27 Participants
International Normalized Ratio (INR)	2 Ratio STANDARD_DEVIATION 0.997	2 Ratio STANDARD_DEVIATION 1	2 Ratio STANDARD_DEVIATION 1
Oral Anticoagulant (OAC)	65 Participants	32 Participants	33 Participants
Platelets	211.41 Platelets*1000 STANDARD_DEVIATION 68.59	213 Platelets*1000 STANDARD_DEVIATION 65	210 Platelets*1000 STANDARD_DEVIATION 72
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	1 Participants	2 Participants
Race (NIH/OMB) White	144 Participants	68 Participants	76 Participants
Region of Enrollment United States	147 participants	69 participants	78 participants
Serum Creatinine (Serum Cr)	1.16 mg/dL STANDARD_DEVIATION 0.45	1.17 mg/dL STANDARD_DEVIATION 0.45	1.15 mg/dL STANDARD_DEVIATION 0.46
Sex: Female, Male Female	46 Participants	22 Participants	24 Participants
Sex: Female, Male Male	101 Participants	47 Participants	54 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

Pocket Hematoma, Moderate-Severe

A pocket hematoma is an accumulation of blood in or near the surgical incision which occurs because of a defect in hemostasis such as injury to blood vessels. Pocket hematoma is associated with local discomfort, an increased risk of infection, and may require surgical intervention or lead to lengthier hospital stays. Mild - Ecchymosis or mild effusion in the pocket, no swelling or pain to device-pocket (watchful waiting) Moderate - Large effusion in the pocket leading to swelling and causing functional impairment or pain to device-pocket Severe - Any pocket hematoma requiring: Reoperation and/or resulting in prolongation of hospitalization (defined as extended hospitalization or rehospitalization for \>24 hours, postindex surgery, primarily due to hematoma) and/or requiring interruption of OAC (defined as reversal or intentional withholding, in response to pocket hematoma, resulting in subtherapeutic anticoagulation for \>24 hours)

Time frame: 7-10 days post implant

Arm	Measure	Value (NUMBER)
Silverlon®	Pocket Hematoma, Moderate-Severe	2 participants
AQUACEL® AG	Pocket Hematoma, Moderate-Severe	2 participants

Secondary

Pocket Dehiscence

Pocket (Wound) Dehiscence: Dehiscence is a partial or total separation of previously approximated wound edges, due to a failure of proper wound healing. It may be just the surface layer or the whole wound.This scenario typically occurs 5 to 8 days following surgery when healing is still in the early stages.